PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 11461803

Monotherapy trials: sequential design.

J Whitehead
View original source ↗Export metadata ↓

Abstract

In a sequential clinical trial, the accumulating data are subjected to a series of interim analyses, each of which involves a comparison of the treatments under study in respect of the primary efficacy criterion. The trial is stopped as soon as it is evident that one treatment is superior to the other, or that no such difference is going to be found. The stopping rule is devised to ensure that the required significance level and power are achieved and that valid statistical inference can be drawn at the end of the study. The methodology will be presented by means of a case study. This is the SEReNE study, which was completed last year and compared remacemide with carbamazepine in the treatment of newly diagnosed epilepsy. The study employed a double triangular test: an efficient form of sequential design for the comparison of two active treatments. The primary efficacy response was time from randomisation to the first seizure following dose titration. Details will be given of the stopping rule employed, the number of patients forecasted, the progress of the trial and its final analysis. The procedure adopted will be reviewed, and its suitability for future trials assessed.

Explore related subjects

AnticonvulsantsClinical Trials as TopicEpilepsyHumansResearch DesignJournal ArticleReview

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

J Whitehead. 2001. Monotherapy trials: sequential design.. https://doi.org/10.1016/s0920-1211(01)00224-8

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2003

The treatment of epilepsy in developing countries: where do we go from here?

Epilepsy is the most common serious neurological disorder and is one of the world's most prevalent noncommunicable diseases. As the understanding of its physical and social burden has increased it has moved higher up the world health agenda. Over four-fifths of the 50 million people with epilepsy are thought to be in developing countries; much of this condition results from preventable causes. Around 90% of people with epilepsy in developing countries are not receiving appropriate treatment. Consequently, people with epilepsy continue to be stigmatized and have a lower quality of life than people with other chronic illnesses. However, bridging the treatment gap and reducing the burden of epilepsy is not straightforward and faces many constraints. Cultural attitudes, a lack of prioritization, poor health system infrastructure, and inadequate supplies of antiepileptic drugs all conspire to hinder appropriate treatment. Nevertheless, there have been successful attempts to provide treatment, which have shown the importance of community-based approaches and also indicate that provision for sustained intervention over the long term is necessary in any treatment programme. Approaches being adopted in the demonstration projects of the Global Campaign Against Epilepsy--implemented by the International League Against Epilepsy, the International Bureau for Epilepsy, and the World Health Organization--may provide further advances. Much remains to be done but it is hoped that current efforts will lead to better treatment of people with epilepsy in developing countries.

Anticonvulsants↗
PubMed2002

Bipolar disorder.

Bipolar, or manic-depressive, disorder is a frequent, severe, mostly recurrent mood disorder associated with great morbidity. The lifetime prevalence of bipolar disorder is 1.3 to 1.6%. The mortality rate of the disease is two to three times higher than that of the general population. About 10-20% of individuals with bipolar disorder take their own life, and nearly one third of patients admit to at least one suicide attempt. The clinical manifestations of the disease are exceptionally diverse. They range from mild hypomania or mild depression to severe forms of mania or depression accompanied by profound psychosis. Bipolar disorder is equally prevalent across sexes, with the exception of rapid cycling, a severe and difficult to treat variant of the disorder, which arises mostly in women. Because of the high risk of recurrence and suicide, long-term prophylactic pharmacological treatment is indicated. Lithium salts are the first choice long-term preventive treatment for bipolar disorder. They also possess well documented antisuicidal effects. Second choice prophylactic treatments are carbamazepine and valproate, although evidence of their effectiveness is weaker.

Anticonvulsants↗